The truth about hospital formularies
Survey shows many myths still exist 15 years later

From the February 10, 2005
issue

Ideally, a carefully selected drug formulary guides
clinicians in choosing the safest, most effective agents for
treating medical problems. But, in 1990, Rucker and Schiff(1)
documented that full realization of this potential had been
thwarted by misconceptions and myths. Fifteen years later,
many of these same myths are still in existence, according
to 265 respondents to our November 2004 survey. Respondents
were asked to report the frequency with which specific comments
illustrative of these myths had been made during 2004 formulary
deliberations at their Pharmacy and Therapeutic (P&T)
Committee meetings. Interestingly, all eleven of the myths
presented in the survey had been encountered by at least 19%
of the respondents during 2004. Reviewing just a few of the
most frequently encountered myths reveals that formulary deliberations
today may still be centered less on the critical evaluation
of scientific data, and more on misconceptions about formularies.

The specialist knows best was the most
common myth encountered during P&T Committee meetings.
Almost three-quarters of respondents (74%) reported theyd
received comments suggesting it was presumptuous for non-subspecialists
to play a role in formulary decisions for specialty drugs.
About one in five (19%) reported frequent comments, and
73% of all respondents who encountered this myth told us
that the comments impacted formulary decisions. While specialists
must be represented and consulted regarding formulary drugs
within their specialty, nothing should preclude the P&T
Committee from pursuing a thorough evaluation of each formulary
request. Specialists are particularly adept at interpreting
and presenting data on drugs in their area of interest,
but a multidisciplinary peer group best evaluates clinical
efficacy. Furthermore, safety is best evaluated by an interdisciplinary
group of healthcare providers (physicians, pharmacists,
nurses) who, collectively with specialists, may uncover
otherwise unrecognized safety hazards to address before
using the drug. Additionally, when research is involved,
a thorough formulary review process can help avoid even
the appearance of conflict of interest, and clearly separate
drug prescribing for research purposes from patient therapy.

Causal empiricism was the basis for
another frequently encountered myth. Again, three-quarters
(75%) of respondents reported assertions from physicians
that favorable experiences, replete with personal cases
or anecdotal observations, justify the addition of a new
drug to the formulary, at least for a trial
period for the medical staff to evaluate the
drug. Twelve percent of respondents reported hearing these
types of comments often during formulary deliberations,
and almost three-quarters (70%) of all respondents who encountered
this myth reported that the comments impacted formulary
decisions. Physicians are well aware of the importance of
practicing evidence-based medicine, which fundamentally
includes the need for randomized, blinded drug studies to
prove efficacy and safety. But they may be unprepared to
treat their own favorable experiences with skepticism, and
may rely too heavily on their own abilities to evaluate
the efficacy and safety of a new product. Thus, they may
assume that their personal clinical impressions about the
product are crucial to determine the quality of drug therapy,
rather than relying on the P&T Committees evaluation
of available scientific evidence.

Sicker patients need more drugs was
another myth heard by almost three-quarters (74%) of respondents.
Thirteen percent reported hearing comments related to this
myth often during formulary deliberations, and two-thirds
(67%) of all respondents who encountered this myth reported
that the comments impacted the formulary decision. While
most formularies include second-line alternatives for specified
classes of medications, the assumption that sicker patients
need more intensive pharmacotherapy, or more choices among
available products, is only warranted if there is evidence
of benefit. Some physicians may also claim that a strictly
controlled formulary can cause life-threatening delays if
an alternative non-formulary drug must be obtained. However,
lack of therapeutic restraint and standardized protocols
that carefully spell out how to handle emergencies well
in advance - not the absence of a particular drug - have
long been identified as major factors in iatrogenic injuries
and catastrophic outcomes.

The formulary interferes with clinical freedom
was cited as a problem by two-thirds (67%) of respondents.
Twelve percent reported frequent comments, many of which
explicitly challenge the formulary concept. More than half
(53%) of all respondents who encountered this problem reported
that the comments impacted formulary decisions. Yet, the
basic underlying tenets of an effective formulary include:
(1) acknowledgment that each clinician prescribes a very
limited subset of available products, (2) recognition that
a formulary prepared by a group of experts and peers with
adequate resources is likely more optimal than a clinicians
personal formulary, and (3) preservation of clinical freedom
by providing broad therapeutic decision- making guidance,
not interference with prescribing.

Widespread use equals drug of choice
was another claim encountered during formulary deliberations
by almost three-quarters of respondents (72%). Nine percent
of respondents reported frequent comments promoting formulary
addition of products due to widespread use, increased patient
demand, and more subtle variations on this theme, including
potential loss of competitiveness because other hospitals
are using the drug. Almost two-thirds (65%) of all respondents
who encountered these claims reported that they impacted
formulary decisions. However, widespread use may be more
a measure of marketing success than comparative benefits
of the product, especially in light of the rapid acceptance
of new drugs that ultimately proved to be potentially harmful,
and the inappropriate prescribing of some high volume medications.

Perpetuation of these formulary myths and others initially
covered by Rucker and Schiff(1) can be traced back to many
factors, including assertions from the pharmaceutical industry
that formularies inhibit prescriber knowledge of their products
and freedom to use any FDA- approved medications. Nonexistent
didactic training about using formularies as a powerful
patient safety/quality tool, rather than a restrictive cost-containment
strategy, during medical and pharmacy training also hinders
progress and allows reinforcement of biased, negative feelings
about formularies. Sadly, one things clear from our
recent survey: tapping into the enormous potential of formularies
will be a marathon in healthcare, not a sprint.

Holding frank discussions about the formulary myths presented
in our November 2004 survey could prove to be one giant
step on this journey toward optimal care for patients. Focused
attention on the theoretical foundation and operational
parameters of formularies by health professional schools,
the research community, and funding agencies could also
result in identification of the most appropriate role of
drug formularies in society today.